Jurors Turn an Experienced Eye Toward Design

Gail D. Baura, PhD, is a professor at Keck Graduate Institute of Applied Life Sciences in Claremont, CA. She teaches classes in the medical devices and diagnostics track and is one of the nation’s foremost experts on system theory applied to patient monitoring. She previously served as vice president for research and chief scientist at Cardiodynamics. She also wrote the first textbook combining system theory and patient monitoring, which reviewed cases applying system theory to various detection and measurement algorithms. A senior member of the Institute of Electrical and Electronics Engineers (IEEE), she belongs to IEEE’s Signal Processing Society and Engineers in Medicine and Biology Society. She is an associate editor of IEEE’s Engineering in Medicine and Biology Magazine and is an ABET program evaluator for bioengineering and biomedical engineering. Baura holds 19 U.S. patents and has another one pending.

Jim Best is a founding partner of Pensa (Brooklyn, NY), a strategic design consultancy. He started his career designing medical equipment for companies such as Becton Dickinson, Biomedic Data Systems, and Bayer Diagnostics. He later worked at Smart Design and Machineart as a senior industrial designer, leading all aspects of the design process. Best has designed products for a wide range of categories including consumer electronics, childcare, consumer packaged goods, furniture, housewares, medical devices, and home healthcare. His work has been recognized with awards such as Businessweek/IDEA gold, Medical Design Excellence Award, and the Chicago Athenaeum Good Design award. Best has a BFA in Industrial Design from Carnegie Mellon University and an MBA in Marketing from Fordham University.

Yadin B. David, PhD, is founder of Biomedical Engineering Consultants LLC (Houston), a firm that provides assessment of medical technology management operations, regulatory compliance, and forensic engineering services for hospitals and industry. For the previous 25 years, David headed the biomedical engineering department and the Center for Telehealth at Texas Children’s Hospital (Houston). In addition to having headed large hospital biomedical engineering departments, he holds academic appointments at the Baylor College of Medicine Department of Pediatrics, at the University of Texas, School of Public Health, and is a visiting professor at the Tec de Monterrey school of Medicine in Mexico. David has been a member of several FDA advisory panels, and he is the recipient of the FDA commissioner’s special citation. In addition, he also received the 2008 ACCE/AAMI Robert L. Morris Humanitarian Engineering award. David has served as an adviser to the Pan American Health Organization and as president of the Center for Telemedicine and eHealth Law, both in Washington, DC.

Peter M. Denk, MD, is a minimally invasive surgeon specializing in laparoscopic and endoscopic abdominal surgery. He serves as the director of endoscopic surgery at Bluegrass Bariatrics (Lexington, KY), offering advanced laparoscopic procedures such as single-port adjustable gastric banding and gastric sleeve and bypass as well as cutting-edge endolumenal procedures. Denk performed the first POSE (Primary Obesity Surgery, Endolumenal) in the United States in February of 2009. He was also part of the team of surgeons that performed the first Transgastric Natural Orifice Cholecystectomy (gallbladder removal through the mouth) in the United States in Portland, OR, in May of 2007. Denk started Innovation Development LLC., a consulting company devoted to surgical device and procedure development for Natural Orifice in single incision surgery. Innovation Development works closely with USGI Medical, a California company, to develop noninvasive surgical treatments for obesity both clinically and in device R&D.

Prakash Gatta, MD, is an assistant professor of surgery at the University of Cincinnati and cofounder and chief medical officer of Single Port Solutions LLC. He is also a practicing and board-certified surgeon with a staff appointment in the division of general surgery at the University of Cincinnati’s University Hospital. His clinical focus is esophageal and gastric surgery, with an emphasis on new, minimally invasive approaches to common surgical procedures. In 2007, he was part of a team that performed the first trans-oral incisionless cholecystectomy in the United States. He is the coinventor and holds patents on single-port laparoscopic access tools.

Sean Hägenfounded BlackHägen Design (BH; Dunedin, FL) in 1995 and has initiated or coinvented more than 85 patents for a range of companies. His current focus at BH is the user research and synthesis phase for product development, which includes ethnography, human factors, usability testing, and conceptualization and translation of research insights into robust user requirements. The synthesis of user insights into design inputs and concepts by Hägen has launched development projects for clients such as Edwards Lifesciences and Ethicon Endo-Surgery. In projects for clients such as Medtronic, Philips Healthcare, and Terumo, Hägen has contributed to the research and development of Class I, II, and III devices as the principal investigator, project manager, designer, and usability specialist. He is currently the medical section chair for the Industrial Design Society of America.

Balakrishna Haridas, PhD, is president of Device & Implant Innovations LLC (Mason, OH), a consulting company conducting early-stage R&D projects for U.S. medical device companies. He formerly served as the founder and director of the National Science Foundation Minimally Invasive Medical Technologies Center and as an associate professor in the Department of Biomedical Engineering at the University of Cincinnati. Haridas has more than 18 years of experience in R&D and commercialization of technologies and products for minimally invasive surgery and soft tissue repair. He holds a BE in civil engineering from Bangalore University (India), an MS in engineering mechanics from the University of Alabama, and a PhD in Biomedical Engineering/Biomechanics from the University of Cincinnati.

Denise M. Korniewicz, PhD, is a professor and senior associate dean for research at the University of Miami School of Nursing and Health Studies, where she also serves as director of the nursing school’s research center. Her chief areas of expertise include research, grant development, graduate student mentoring, and assisting device companies in the development of patient safety equipment. After earning nursing degrees at Madonna University (BS), Texas Woman’s University (MS), and the Catholic University of America (PhD), Korniewicz did postdoctoral work in infection prevention at the Johns Hopkins University School of Nursing. She gained experience in the management of critical care patients as an emergency room charge nurse before undertaking an academic career that has included professorships at the University of Maryland Schools of Nursing & Medicine, Georgetown University Schools of Nursing & Medicine, and the Johns Hopkins School of Nursing. Her practical nursing experience began in the U.S. Army Nurse Corps, which she left with the rank of captain.

Pascal Malassigné is a professor of industrial design at the Milwaukee Institute of Art and Design, a career research scientist, and industrial designer at the Milwaukee Veterans Affairs Medical Center. He is also an adjunct assistant professor of rehabilitation at the Medical College of Wisconsin in Milwaukee. He is one of the nation’s foremost designers of assistive and mobility products for the elderly and those with disabilities. For the past 25 years, his research has been funded by the U.S. Department of Veterans Affairs and has led to the design of patented products from commode-shower wheelchairs to bathing fixtures, mobility carts, and bedrails. Malassigné has more than 35 years of experience teaching industrial design, and taught at Georgia Tech and Virginia Tech universities before coming to Milwaukee in 1991.

Richard Meyst is president and CEO of Fallbrook Engineering Inc. (Escondido, CA), a contract product development, management, and engineering services consulting firm specializing in healthcare products. He is also president and CEO of Cord Cell Technologies, a start-up company commercializing products for cellular therapy. In his career, he has been associated with many of the premier medical device manufacturers. He has been heavily involved with the development of high-volume sterile disposables using a wide range of polymers. Products he has designed have utilized manufacturing technologies such as injection molding, transfer molding, extrusion, thermoforming, solvent and adhesive bonding, and sonic welding. Meyst holds 13 U.S. patents.

Mark Vreeke, PhD, is senior partner at Rational Systems LLC (Houston), a business process and technical consulting firm. He has been the lead consultant on multiple IVD projects ranging from blood glucose monitors to multianalyte clinical analyzers. He also serves as vice president of R&D for Rational Biotechnology, a spin-off of Rational Systems whose goal is to speed the adoption of personalized medicine through the development of combined IVD and drug therapy products. In 2007, Vreeke started TransAtlantic Science to commercialize the Lactate EDGE, a sports exercise monitor. The company has subsequently moved into the contract research arena, specializing in glucose monitoring. It has also initiated an internal effort in diabetes control.

Stephen Wilcox, PhD, is principal and founder of Design Science (Philadelphia), a 20-person firm that specializes in optimizing the human interface of medical products. Wilcox is a member of the Industrial Designers Society of America’s (IDSA) Academy of Fellows and has served as a vice president and member of the IDSA Board of Directors. He also serves on the human engineering committee of the Association for the Advancement of Medical Instrumentation, which has produced the HE 74 Human Factors standard for medical devices and the forthcoming HE 75. He has won design awards from IDSA and from International Design magazine, including a 2009 Gold IDEA award for research supporting Ethicon Endo-Surgery's Harmonic Focus. His book Designing Usaility into Medical Products, coauthored with Michael Wiklund, was published in 2005.